Reliable Compounding Pharmacy Recalls All Compounded Tacrolimus Products
Reliable Compounding Pharmacy is recalling all compounded tacrolimus products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific injuries or illnesses are reported in the source text, and the hazard is a lack of processing controls rather than a specific pathogen or structural defect.
Plain-English summary
Reliable Rexall-A Compounding Pharmacy is recalling all compounded tacrolimus products. The recall is being conducted due to a lack of processing controls. The affected products are prescription-only medications compounded by Reliable Drug/Reliable Compounding Pharmacy located in San Francisco, California.
The recall includes all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates. The products were distributed in the United States, specifically in California, Hawaii, and New Mexico.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Manufacturer
- Reliable Rexall-A Compounding Pharmacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..
Distribution
Part of a larger recall action
This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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